MHRA Specials vs parallel import: what a UK procurement manager is actually buying, and when each route applies.

In a UK hospital procurement meeting you will hear the terms Specials and parallel import used as if they were variations on the same theme. They are not. One is an unlicensed medicine made to order under a prescriber's clinical responsibility. The other is a fully licensed medicine brought in from another country under a separate authorisation issued by MHRA. This piece is the explainer we wish every first-time buyer read before writing the brief.

The mechanical difference in one paragraph.

An MHRA Special is an unlicensed medicine manufactured or imported against a specific prescriber's order for an identified patient, under Regulation 167 of the Human Medicines Regulations 2012, where no UK-licensed equivalent meets the clinical need. A parallel import is a medicine that already holds a Marketing Authorisation in another country whose regulatory standards MHRA recognises, re-labelled and re-packaged for the UK market under a separate Parallel Import Licence (PIL) granted by MHRA for that specific product-and-source pair. Specials sit outside the Marketing Authorisation framework and rely on the prescriber. Parallel imports sit firmly inside it and rely on the PIL. That single sentence is the difference that decides everything else in this piece.

MHRA Specials, the unlicensed route.

The statutory basis for Specials is Regulation 167 of the Human Medicines Regulations 2012. The regulation permits the supply of an unlicensed medicinal product against a prescription issued by a UK-registered prescriber for an individual patient, where a suitable licensed equivalent does not exist or does not meet the patient's clinical needs. The route is unlicensed on purpose: the product itself has no UK Marketing Authorisation, and clinical responsibility sits with the prescriber.

The manufacturer or importer must hold an MHRA Specials Manufacturer's Licence (MS Licence). The MS Licence authorises the activity — manufacturing, assembling or importing the Special — rather than any specific product. This is the distinction buyers most often miss: an MS-licensed supplier is not pre-approved to sell any product to you. They are approved to carry out Specials activity to a defined standard.

Typical triggers for a Specials order:

• Licensed UK product exists but the excipient is wrong for an allergic patient — a lactose-free, gluten-free or preservative-free formulation is needed.
• Licensed UK strength is wrong — a paediatric liquid at a specific mg/mL that no MA covers.
• Licensed dosage form is wrong — a swallowing-impaired patient needs a suspension, not a tablet.
• No UK-licensed equivalent exists at all — a molecule licensed elsewhere, or never licensed anywhere, prescribed on clinical grounds.

MHRA's reference document for the route is Guidance Note 14: The Supply of Unlicensed Medicinal Products (Specials). A buyer should work from the current published version on gov.uk and not from a cached PDF.

Parallel import, the licensed-elsewhere route.

Parallel import is the mirror image. The product is licensed — just not in the UK. A manufacturer or wholesaler identifies a Marketing Authorisation issued in another country whose regulatory standards MHRA recognises, sources packs bearing that foreign licence, and re-labels or re-packages them for the UK market. The re-labelled pack is then sold in the UK under a separate authorisation: the Parallel Import Licence (PIL), granted by MHRA for that specific source product against a specific UK-licensed equivalent.

Before Brexit this was handled under the EU's parallel-distribution framework harmonised with the European Medicines Agency. Post-Brexit, MHRA operates its own PIL system. The substantive test has not moved very far: the imported product must have the same active ingredient, the same therapeutic indication and the same pharmaceutical form as an existing UK-licensed product, with any formulation differences declared and reviewed.

Two things to remember. First, a PIL is granted for the pair — source product and UK reference — not for the source product on its own. Second, the re-label and re-pack process itself is regulated; the PIL holder must demonstrate that re-packaging does not compromise stability or identification, usually through stability data on the re-packaged pack format.

Common commercial drivers for parallel import:

• Price arbitrage — an EU-labelled pack is cheaper than the UK-licensed equivalent, the difference survives the re-labelling cost, and a tender becomes competitive.
• UK supply shortage — the UK-licensed product is on a manufacturer-declared shortage, and a parallel-imported pack of the same molecule clears NHS supply gaps.
• Pack-size availability — a foreign pack size suits a dispensing pattern the UK MA does not carry.

When UK procurement uses which.

The decision tree is cleaner than the language suggests. Ask two questions in order.

1. Is there a UK-licensed product that meets the clinical need? If yes, procurement should default to the UK-licensed product. Parallel import only enters if there is a price, availability or pack-size reason to prefer a foreign-licensed source of the same molecule. Specials do not enter at all — a Special against an available, suitable licensed product is not permitted.
2. If the answer to the first question is no, is there a suitable foreign-licensed equivalent? If yes, the route is parallel import — subject to a PIL being granted or already in place. If no, the route is a Special under Regulation 167, or a named-patient import of an unlicensed medicine from a foreign jurisdiction, which is a third route distinct from both Specials and parallel import.

In practice the three routes overlap at the edges, which is why procurement briefs often get mis-filed. A molecule that is licensed in Germany but not in the UK, and where the clinical need is for the German brand specifically, can often be sourced as a parallel import if a PIL is in place — or as a named-patient import if not — or as a Special if the prescriber is writing for a specific formulation that neither the UK nor the German MA covers. The buyer's job is to identify which of the three the request actually is. The supplier's job is to confirm it.

The paperwork realities.

The documentation footprint differs sharply, and it is the cleanest way to tell the routes apart in a procurement file.

Specials paperwork

• A prescription from a UK-registered prescriber, naming the patient or a specific clinical context, and confirming the clinical need for an unlicensed product.
• The MS licence number of the manufacturer or importer, and a supply record tying the batch to the prescription.
• A Certificate of Analysis for the specific batch from the manufacturing site.
• A WHO-GMP or EU-GMP certificate of the manufacturing site where the Special was made.
• Product-information leaflet or patient-facing documentation prepared for the unlicensed product — not the full UK MA Patient Information Leaflet, which does not apply.
• An MHRA notification for imports of unlicensed medicines from outside the UK (the relevant MHRA import notification form — buyers should reference the current version on gov.uk rather than assume a form code that may have changed).

Parallel import paperwork

• The PIL itself — the Parallel Import Licence number granted by MHRA for that source-and-UK-reference pair.
• The source-country Marketing Authorisation and supporting pack artwork.
• The UK-licensed reference product's Summary of Product Characteristics, against which the imported product was judged equivalent.
• Stability data on the re-packaged format, demonstrating the re-labelling or re-packing process does not compromise the product.
• A Marketing Authorisation Holder (MAH) variation trail where the UK reference has been updated since the PIL was granted.
• Standard wholesale-dealer release paperwork — QP certification where required, batch records, cold-chain data.

The two piles look nothing alike. If a supplier sends you a file that mixes them — an MS licence number next to a PIL reference — you are probably looking at a cover letter that has been written hastily.

Where both routes go wrong in procurement.

Three procurement errors account for most of the queries that reach our desk from UK buyers who have already signed a contract and then hit a problem.

1. Assuming the MS Licence covers the product. The Specials Manufacturer's Licence authorises the manufacturing and supply activity, not a specific product or formulation. A buyer who treats an MS licence number as if it were a Marketing Authorisation is building a procurement argument on a foundation the regulation does not support. Every Special is a standalone unlicensed event. The licence tells you the supplier is authorised to do the work; it does not tell you that this particular product has been cleared.
2. Assuming an EU licence means parallel import is automatic. A product's EU or EEA licence is a necessary but not sufficient condition for parallel import into Great Britain. MHRA must have granted a PIL for that specific source product against the relevant UK reference. Without the PIL, the product is not a parallel import — it is either an unlicensed medicine moving as a named-patient import, or it is not legally saleable to the UK wholesale chain at all. “CE-marked” and “EU licensed” are not shorthand for “parallel-importable.”
3. Confusing Specials with extemporaneous compounding. A compounded or extemporaneous preparation is made in the pharmacy at the point of dispensing, under the pharmacist's own responsibility, typically for a single patient and a single prescription. A Special is made by a separate MS-licensed manufacturer. The two routes are often used interchangeably in conversation and they are not interchangeable in regulation — a Special is subject to MS-licence GMP oversight; an extemporaneous preparation is subject to the supervising pharmacist's professional responsibility. A tender that specifies one and accepts the other is a tender that will not stand up to a post-award audit.

A fourth, smaller trap: parallel-import paperwork often arrives without the stability data that supports the re-packed pack format. The PIL file assumes it. A procurement desk checking the pack on receipt should too.

FAQ

Is an MHRA Special a licensed medicine?

No. A Special is by definition unlicensed. The product has no UK Marketing Authorisation. The regulatory basis is Regulation 167 of the Human Medicines Regulations 2012, which permits supply against a UK prescriber's order for a patient whose clinical need is not met by any licensed UK product. Clinical responsibility sits with the prescriber, not the MHRA, and not the Specials manufacturer. The Specials Manufacturer's Licence (MS Licence) covers the manufacturing and supply activity; it does not licence any individual product.

Is a parallel-imported medicine the same as the UK-licensed version?

Clinically equivalent, not identical. A parallel-imported pack must have the same active ingredient, the same pharmaceutical form and the same therapeutic indication as an existing UK-licensed reference, but the source pack may differ in excipients, pack size, artwork and country-specific labelling. MHRA grants the Parallel Import Licence (PIL) for a specific source-and-UK-reference pair, and the re-labelling or re-packing process is itself regulated. A procurement desk should verify the PIL is current, the UK reference has not been varied since the PIL was granted, and the stability data on the re-packaged format is on file.

Where does named-patient import fit between the two?

Named-patient import is a separate route from both Specials and parallel import. It covers the supply of a medicine that is not UK-licensed — and typically not parallel-imported either — from a foreign manufacturer to a UK hospital pharmacy or MHRA-licensed importer, for a specific named patient. It uses Regulation 167 as its legal basis in the same way Specials do, but the product itself is imported from a foreign jurisdiction rather than manufactured by a UK-based MS-licensed Specials manufacturer. We run the named-patient route into UK hospital pharmacies from our Mumbai desk, and it is usually the right answer when neither a UK MA nor a UK PIL covers the request.

How does M Care fit into the Specials and parallel-import chain?

We are the Indian manufacturer-side supplier. M Care does not itself hold an MHRA MS Licence, a Parallel Import Licence or a UK Wholesale Dealer's Licence — those are UK-held authorisations. We supply finished-dose unlicensed medicines and active pharmaceutical ingredients into UK MS-licence holders, PIL holders and WDA(H) wholesalers, and we ship named-patient consignments directly to UK hospital pharmacies under Regulation 167. If you are weighing Specials, parallel import or named-patient for a specific molecule and volume, send us the brief and we will tell you which route fits and what the file should look like.